Primary Progesterone Therapy for Operable Breast Cancer
NCT ID: NCT00123669
Last Updated: 2020-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
1000 participants
INTERVENTIONAL
1997-10-31
2020-05-29
Brief Summary
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* Circulating progesterone at the time of surgery might counteract the detrimental effect of estrogen on survival of women with operable breast cancer.
* Events at the time of surgery may have an impact on the natural history of breast cancer
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Patient will not receive Inj Progesterone 500 mg
No interventions assigned to this group
Treatment
An intramuscular injection of 500mg depot hydroxy-progesterone 5-14 days prior to surgery.
500 mg of depot hydroxy-progesterone
An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.
Interventions
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500 mg of depot hydroxy-progesterone
An intramuscular injection of 500 mg of depot hydroxy-progesterone 5 to 15 days prior to surgery.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of other epithelial/mesenchymal malignant tumours except basal cell carcinoma/squamous cell carcinoma (BCC/SCC) of skin
18 Years
75 Years
FEMALE
No
Sponsors
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Ministry of Science and Technology, India
OTHER_GOV
Tata Memorial Hospital
OTHER_GOV
Responsible Party
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Dr Rajendra A. Badwe
Director
Principal Investigators
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Rajendra A Badwe, M.S.
Role: PRINCIPAL_INVESTIGATOR
Professor & Head, Department of Surgical Oncology, Chief Breast Unit
Locations
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Tata Memorial Hospital
Mumbai, Maharashtra, India
Countries
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References
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Badwe RA, Wang DY, Gregory WM, Fentiman IS, Chaudary MA, Smith P, Richards MA, Rubens RD. Serum progesterone at the time of surgery and survival in women with premenopausal operable breast cancer. Eur J Cancer. 1994;30A(4):445-8. doi: 10.1016/0959-8049(94)90415-4.
Badwe RA, Gregory WM, Chaudary MA, Richards MA, Bentley AE, Rubens RD, Fentiman IS. Timing of surgery during menstrual cycle and survival of premenopausal women with operable breast cancer. Lancet. 1991 May 25;337(8752):1261-4. doi: 10.1016/0140-6736(91)92927-t.
Badwe RA, Bettelheim R, Millis RR, Gregory W, Richards MA, Fentiman IS. Cyclical tumour variations in premenopausal women with early breast cancer. Eur J Cancer. 1995 Dec;31A(13-14):2181-4. doi: 10.1016/0959-8049(95)00301-0.
Badwe RA, Mittra I, Havaldar R. Timing of surgery with regard to the menstrual cycle in women with primary breast cancer. Surg Clin North Am. 1999 Oct;79(5):1047-59. doi: 10.1016/s0039-6109(05)70060-8.
Badwe RA, Hawaldar RW. Effect of menstrual phase on surgical treatment of breast cancer. Lancet. 1994 Aug 6;344(8919):404. No abstract available.
Badwe RA, Juvekar RR. Timing of breast cancer surgery during the menstrual cycle. Ann Oncol. 1994 Jan;5(1):29-31. doi: 10.1093/oxfordjournals.annonc.a058682. No abstract available.
Badwe R, Hawaldar R, Parmar V, Nadkarni M, Shet T, Desai S, Gupta S, Jalali R, Vanmali V, Dikshit R, Mittra I. Single-injection depot progesterone before surgery and survival in women with operable breast cancer: a randomized controlled trial. J Clin Oncol. 2011 Jul 20;29(21):2845-51. doi: 10.1200/JCO.2010.33.0738. Epub 2011 Jun 13.
Other Identifiers
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No. SP/SO/B29/2000
Identifier Type: -
Identifier Source: org_study_id
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